Laser Ablation for Prostate Cancer

(TPF-LITT Trial)

Overseen By Luanda Perez, PA.C

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Urological Research Network, LLC

Disqualifiers: Neurological conditions, Neurogenic bladder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 day

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat prostate cancer using a laser therapy called TFA-LITT (TRANBERG® Transperineal Fusion Laser-Induced Thermal Therapy of Prostate Cancer). The researchers aim to determine if this treatment is safe and well-tolerated when performed in a doctor's office, potentially posing less risk than surgery or radiation. The trial focuses on men with low to intermediate risk prostate cancer, targeting only the cancerous part of the prostate while sparing the rest of the organ. Men with prostate cancer affecting less than one-third of the gland and no major urinary issues might be suitable candidates for this study. As an unphased trial, it offers a unique opportunity to contribute to innovative treatment approaches for prostate cancer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this laser device is safe for prostate cancer treatment?

Research has shown that laser ablation for prostate cancer could be a safe option for men with low to intermediate risk. Patients have generally tolerated this treatment well, with many not experiencing severe side effects.

The laser treatment uses heat to target and destroy cancer cells in the prostate. One study found that this method can serve as a safe and effective alternative to more invasive treatments like surgery. The FDA has approved it for this type of therapy, indicating its safety for certain uses.

Overall, the treatment aims to protect healthy parts of the prostate while removing cancerous cells. This approach may help avoid common side effects of traditional treatments, such as impotence and loss of bladder control. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TRANBERG® Transperineal Fusion Laser-Induced Thermal Therapy (TPF-LITT) because it offers a unique approach to treating prostate cancer. Unlike traditional treatments like surgery, radiation, or hormone therapy, TPF-LITT uses a laser device combined with imaging fusion to precisely target and ablate only the cancerous part of the prostate. This method potentially reduces damage to surrounding healthy tissue, which may lead to fewer side effects and a quicker recovery. Additionally, this precision-driven approach might offer a more personalized treatment option, which is a significant advancement over the more generalized methods currently available.

What evidence suggests that this device is effective for prostate cancer?

Research has shown that laser-induced thermal therapy (TFA-LITT), which participants in this trial will receive, could be a promising treatment for prostate cancer. Studies have found that this laser treatment safely targets and destroys cancer cells while preserving healthy tissue. This approach helps maintain important functions and reduces the risk of side effects like impotence and incontinence. Additionally, it can be performed in an outpatient setting with local anesthesia, lowering surgical risks. Overall, this laser therapy offers a potential alternative to more invasive procedures, making it an exciting option for individuals with low to intermediate-risk prostate cancer. ^{1 3 4 5 6}

Who Is on the Research Team?

FERNANDO J BIANCO, MD

Principal Investigator

Urological Research Network

Isabel H Lopez, BS., MBA

Principal Investigator

Urological Research Network

Are You a Good Fit for This Trial?

Men aged 50-80 with low to intermediate risk prostate cancer, who can consent and follow the study plan. They should have a prostate size of 18-100 cc by ultrasound or MRI, PSA <20 ng/ml, no urinary retention, creatinine levels <2 ng/dl with GFR >45. Excluded are those with neurogenic bladder issues, poor sexual function scores (SHIM score <14), surgery risks like infection or coagulopathy, high post-void residual urine volume (>250 mL), prior prostate cancer treatments or major neurological conditions.

Inclusion Criteria

I am willing and able to follow all study procedures and attend all visits.

Willing and able to sign informed consent

My prostate size is between 18 and 100 cc according to an MRI.

Exclusion Criteria

I do not have major neurological conditions like Alzheimer's or Parkinson's.

I cannot have local anesthesia due to health reasons.

I cannot have TPFLA surgery due to a health condition like an infection or heart risk.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo TRANBERG® TPF-LITT procedure for prostate cancer ablation under local anesthesia

1 day

1 visit (in-person)

Immediate Post-Treatment Monitoring

Multiparametric MRI conducted immediately after the procedure to assess ablation area

24-72 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including MRI and PROMs assessments

12 months

Multiple visits at 1, 3, 6, 9, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• TRANBERG® Transperineal Fusion Laser--Induced Thermal Therapy of Prostate Cancer (TPF-LITT)

Trial Overview The trial tests TRANBERG® TPF-LITT for treating prostate tumors in an office setting under local anesthesia. It aims to preserve organ function while targeting tumor ablation using fusion imaging guidance. The study will evaluate safety and tolerance of this minimally invasive procedure and its effects on urinary and sexual functions as well as MRI changes in the treated area over time.

How Is the Trial Designed?

Group I: TPF-LITT ARM Experimental Treatment 1 Intervention

partial gland ablation of the prostate using laser device and imaging fusion

TRANBERG® Transperineal Fusion Laser--Induced Thermal Therapy of Prostate Cancer (TPF-LITT) is already approved in United States, European Union for the following indications:

Approved in United States as TRANBERG Thermal Therapy System for:

• Soft tissue ablation, such as prostate tumors

Approved in European Union as TRANBERG Thermal Therapy System for:

• Not specified in provided sources, but generally used for soft tissue ablation including prostate tumors

Who Is Running the Clinical Trial?

Urological Research Network, LLC

Lead Sponsor

Trials

5

Recruited

10,200+

Published Research Related to This Trial

Transperineal laser ablation (TPLA) guided by ultrasound/MR fusion is a safe and effective salvage treatment for patients with refractory focal prostate cancer, as shown in a study of five patients with no recurrence detected over an 18-month follow-up period.

The procedure resulted in a significant reduction in prostate-specific antigen (PSA) levels by over 70%, while preserving quality of life and functional outcomes, indicating its potential as a viable option for managing local recurrences after radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transperineal laser ablation (TPLA) with ultrasound/MRI fusion guidance in the treatment of localized radiotherapy-resistant prostate cancer. Manenti, G., Nezzo, M., Ryan, CP., et al.[2023]

Laser treatment combined with transurethral resection of the prostate shows promise for treating early-stage prostate cancer (T0, T1, and T2) with minimal complications.

In a follow-up study of 26 patients over 6 to 42 months, there have been no recorded local recurrences, suggesting the treatment's efficacy in preventing cancer return.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laser combined with TURP in the treatment of localized prostatic cancer. Samdal, F., Brevik, B.[2019]

Focal laser ablation (FLA) is a promising treatment for low-risk prostate cancer that effectively targets cancerous areas while minimizing damage to surrounding tissues, leading to fewer side effects compared to traditional therapies.

Current phase I clinical trials indicate that FLA provides accurate and reproducible ablation zones, and its effectiveness is being further evaluated in ongoing phase II trials, highlighting its potential as a well-tolerated treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laser ablation as focal therapy for prostate cancer. Wenger, H., Yousuf, A., Oto, A., et al.[2021]

Focal therapy (FT) for prostate cancer shows low side effects across various treatment modalities, with urinary continence rates between 90-100% and erectile dysfunction rates ranging from 5 to 52%.

Expert consensus indicates that different FT techniques may be more effective depending on tumor characteristics: HIFU is preferred for posterior lesions, cryotherapy for anterior tumors, and focal brachytherapy (FBT) for apical lesions, highlighting the need for personalized treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Which technology to select for primary focal treatment of prostate cancer?-European Section of Urotechnology (ESUT) position statement. Ganzer, R., Arthanareeswaran, VKA., Ahmed, HU., et al.[2018]

Focal therapy (FT) for localized prostate cancer shows excellent safety and functional outcomes, with post-operative pad-free rates ranging from 92.3% to 100% across various modalities, based on a review of 107 studies involving 6933 patients.

There is significant variability in erectile function outcomes after FT, with rates ranging from 0% to 94.4% for different treatments, highlighting the need for standardized assessment tools and high-quality comparative studies to better understand these therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional outcomes and safety of focal therapy for prostate cancer: a systematic review on results and patient-reported outcome measures (PROMs). Nicoletti, R., Alberti, A., Castellani, D., et al.[2023]

Laser interstitial thermotherapy (LITT) using a 980-nm diode laser effectively induced necrosis in prostate cancer tumors in a rat model, with significant increases in necrosis volume observed at 1 hour and 48 hours post-treatment.

The study demonstrated a strong correlation between MRI-detected necrosis volumes and histological findings, suggesting that LITT is a reproducible and potentially effective minimally invasive treatment for prostate cancer that warrants further investigation in human subjects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focal laser interstitial thermotherapy (LITT) at 980 nm for prostate cancer: treatment feasibility in Dunning R3327-AT2 rat prostate tumour. Colin, P., Nevoux, P., Marqa, M., et al.[2012]

Transperineal focal laser ablation (TPLA) for prostate cancer was performed successfully in 12 patients with no serious adverse events, indicating its safety as a minimally invasive treatment option.

Imaging techniques like contrast-enhanced ultrasound (CEUS) and MRI effectively visualized the ablation zone, showing a high correlation with histopathological results, confirming no remaining cancer in the treated areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliable Visualization of the Treatment Effect of Transperineal Focal Laser Ablation in Prostate Cancer Patients by Magnetic Resonance Imaging and Contrast-enhanced Ultrasound Imaging. van Riel, LAMJG., van Kollenburg, RAA., Freund, JE., et al.[2023]

Focal laser ablation is a safe and feasible treatment for intermediate risk prostate cancer, with no serious adverse events reported in a trial involving 8 men over 6 months.

While the treatment successfully reduced prostate-specific antigen levels in 7 out of 8 participants, follow-up biopsies indicated that larger treatment margins may be necessary for complete tumor ablation, as cancer was still detected outside the treated area in some cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focal Laser Ablation of Prostate Cancer: Phase I Clinical Trial. Natarajan, S., Raman, S., Priester, AM., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT02759744?term=visualase&recrs=abdf&cond=prostate+cancer&draw=2&rank=3

Fusion Guided Focal Laser Ablation of Prostate Cancer Focal laser ablation for prostate cancer using the Tranberg CLS Thermal Therapy System and laser are FDA cleared. Focal thermal ablation such as laser ablation ...

2. trialx.com trialx.com/clinical-trials/listings/220291/tranberg-transperineal-mrus-fusion-laser-induced-thermal-therapy-for-men-with-prostate-cancer/?&radius=50

TRANBERG® Transperineal MR/US Fusion Laser--Induced ... These treatments have not shown definitive gains in all cause survival and not uncommonly harbor undesirable adverse effects, most notably: impotency and ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39853232/

Transperineal MR Fusion Laser Ablation of Prostate ... Conclusions: TPFLA appears to be a safe and an effective focal therapy for IR-PCa, offering a potential alternative to more radical treatments ...

4. withpower.com withpower.com/trial/phase-prostatic-neoplasms-2-2022-4d82c

Laser Ablation for Prostate Cancer (TPF-LITT Trial) This trial tests a new laser treatment for men aged 50-80 with certain types of prostate cancer. The laser heats and destroys cancer cells, ...

5. liebertpub.com liebertpub.com/doi/10.1089/end.2024.0776

Transperineal MR Fusion Laser Ablation of Prostate ... Conclusions: TPFLA appears to be a safe and an effective focal therapy for IR-PCa, offering a potential alternative to more radical treatments with a minimal ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05826470

Study Details | NCT05826470 | Investigator Initiated Trial to ... Trans-perineal focal laser ablation represents a promising alternative focal therapy option for patients with low-risk or favorable intermediate risk ...